Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.
The clinical scientist is responsible for overall clinical study conduct of Inovio clinical trials including verification of source documentation versus Case Report Forms to ensure accurate and complete data and compliance with protocol(s) and Federal regulations, ICH, & GCPs, and local requirements. Duties may also include oversight of clinical trial operations as performed by a CRO or other external consultants.
Essential job functions and duties
Must meet all requirements for Associate Clinical Scientist position and have demonstrated proficiency in all areas
Fulfill Clinical Project Lead (CPL) responsibilities, as assigned
Author or prepare clinical protocols, informed consent forms, clinical study reports, regulatory documents (e.g., IND, BLA, etc.), and other clinical documents by coordinating input from internal team members and external sources.
Develop and manage study timelines and budgets in collaboration with cross functional teams; mitigate challenges that occur
Complete assigned tasks in accordance with SOPs and guidelines, Good Clinical Practice (GCP), International Council on Harmonisation (ICH) guidelines and regulatory requirements for clinical trial management
Lead multidisciplinary Project Teams to ensure trial deliverables are met according to timelines, budget, quality standards and operational best practices
Independently manage all components of clinical studies to strategically implement clinical development program(s)
Collaborate with strategic sourcing on the development of RFPs and participate in selection of CROs/vendors
Establish strong partnerships with external investigators and collaborators and communicate study-related information to investigators and study staff
Oversee and track recruitment and retention of study subjects
Proactively identify potential operational challenges (e.g., internally/CRO/vendor/investigator) and provide resolution plans and implement solutions to achieve project goals
Develop tools and processes that increase efficiencies of the project
Plan and participate in conduct of Investigator Meetings
Provide protocol and trial specific training at Investigator Meetings and Site Initiation Visits
Assist in determining the activities to support a project’s priorities within functional area
Train CROs, vendors, investigators, and study coordinators on study requirements, as needed
Ensure ongoing activities (e.g., sponsor updates, drug shipments, publications, milestone payments, etc.) for efficient study management and clinical trial execution
Manage and oversee vendors for clinical studies
Initiate, author, and/or contribute to SOP development, implementation and training
Contribute to the development of abstracts, presentations and manuscripts
Coordinate the review of data listings and preparation of interim/final clinical study reports
Provide knowledge and expertise on country specific regulations, site experience, and suitability for development studies
Recruit, hire, manage, mentor, and develop junior staff members (e.g., Associate Clinical Scientist, CTA and/or Clinical Intern), as assigned
Serve as the key operational contact with external investigators and internal stakeholders
Provide progress updates and summaries to supervisor and/or management
Participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
Serve as a resource for others within the company for clinical trials management expertise
Examine functional issues from and organizational perspective
Support inspection readiness and audits as required
Participate in vendor and site audits as needed
Other tasks may be assigned based on skill sets and business need
At least 3+ years of experience and a BS or BA in a relevant scientific discipline
Therapeutic Area(s) experience preferred: Infectious Disease, Vaccines, Oncology, or Women's Health.
Experience with vaccines highly preferred
Regulatory Affairs experience a plus
Medical device experience a plus
MS Office Suite proficiency (Word, Outlook)
Excellent oral and written communication skills, attention to detail and ability to interact effectively with management and prioritize diverse projects for multiple disciplines
Excellent teamwork, communication, decision-making and organizational skills
Thorough understanding of FDA regulations, GCP/ICH guidelines, and ISO requirements is required.
Up to 20%, primarily domestic
Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.
A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.